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    Summary
    EudraCT Number:2004-001538-18
    Sponsor's Protocol Code Number:603-PG-PSC-74
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2004-08-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2004-001538-18
    A.3Full title of the trial
    A randomised, double blinded, placebo controlled multicentre study for the efficacy and safety of Depigoid birch pollen
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number603-PG-PSC-74
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLETI Pharma GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDepigoid Birch
    D.3.2Product code Allergen extract
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients have to suffer from IgE mediated allergic rhinits, rhinoconjunctivitis +/- asthma due to sensitization again birch pollen.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10036019
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For the primary criterion, the area under the curve for the symptom load over the time of exposition will be compared. During the pollen flight time, the active treated group should have a lower symptom load in comparison to the placebo group.
    E.2.2Secondary objectives of the trial
    Secondary parameter considered in this trial will be the following:

    - symptom score
    - medication score
    - specific antibody concentrations (IgG1, IgG4, IgE)
    - pollencount for the different time intervals
    - adverse events
    - oral allergy syndrome
    - quality of life
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Patients of both gender at an age from 6 up to 45 years
    - Prior to study specific examinations, the patient has to give his/her written informed consent. If patients under legal age will be included, the informed consent must be signed by at least one of the parents or the legal responsible guardian.
    - The patients have to suffer from seasonal complaints (rhinitis and/or rhinoconjunctivitis with or without allergic asthma) caused by clinical sensitisation
    against birch pollen. The sensitisation against birch pollen has to be verified by
    - suggestive medical history
    - a positive skin prick test for birch pollen, resulting in a wheal diameter of at
    least 4 mm > negative control reaction or '++' versus histamine
    - specific IgE for birch pollen >= 2
    - Patient’s perception of disease activity of at least 30 mm on a 100 mm visual analogue scale (VAS)
    E.4Principal exclusion criteria
    - pregnant or lactating women
    - women of child-bearing age not employing sufficient contraceptive protection
    - clinical relevant manifestation - defined as positive suggestive history within the last 12 months checked by a comprehensive questionnaire of symptoms, confirmed by a positive skin prick test (wheal diameter of at least 4 mm > negative control reac-tion or '++' versus histamine) as well as by specific IgE (Rast I or higher) - of the following allergies:
    - a perennial allergy against house dust mites (Dermatophagoides pteronyssinus or D. farinae), animal epithelia (of cats or dogs) or mould
    - a seasonal allergy against grasses (included rye) or weeds
    - participation in an immunotherapy with comparable extracts within the last five years
    - participation in another clinical trial within the last 3 month prior to this study
    - any contra-indication for the unspecific bronchial challenge test
    - smokers with a manifested bronchopathy
    - alcohol- or drug abusers
    - persons, who are obviously not compliant
    - patients with other known concomitant diseases:
    - acute tuberculosis
    - inflammatory or infectious diseases of the target organs effective
    - advanced secondary changes at the target organ (e.g. emphysema or bronchiectasis)
    - immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role
    - immune deficiencies
    - history of status asthmaticus, heart- and vascular insufficiency, treatment with beta-blockers
    - any disease which prohibits the use of adrenaline (e. g. hyperthyroidism)
    - serious psychiatric / psychological disturbances
    - concomitant treatment with substances interfering with the immune system
    E.5 End points
    E.5.1Primary end point(s)
    The main parameter in this study is the symptom load during the predefined pollen season. It is defined as the time weighted area under the curve of the daily symptom load including all days of the pollen season. The daily symptom load is the sum of the daily rescue medication score and the daily symptom severity score.

    At the initial and all subsequent examinations, patients will be questioned about their allergic symptoms and the intensity. The same questions are listed in the patient diary. Before the pollen season, the patients will document their symptoms every two weeks, during the pollen season daily.

    Symptom severity:
    Every day / every second week the severity of the day’s/week’s sneezing, itchy nose, runny nose, stuffy nose, itchy eyes, watery eyes and red eyes are evaluated (on a per-symptom basis) using a following 4-point scale.

    Symptom duration
    Every day/week the duration of the day’s itchy nose, runny nose, stuffy nose, itchy eyes, watery eyes, and red eyes are evaluated (on a per symptom basis) using a 4-point scale.

    The weekly/daily symptom severity score of a patient is the mean of all single scores, i.e. the weekly/daily score is ranging from 0 to 3.

    Any rescue medication which is known to have an influence on the typical allergic symptoms is taken into account for the calculation of the weekly/daily rescue medication score. The medication is recorded in the patient’s diary. The following rescue medication will be dispensed and taken into account. Based on the patients condition the following order should be followed:

    - 1. topical nasal medication excluding nasal corticosteroids (disodiumcromoglycate)
    - topical ocular medication excluding topical ocular corticosteroids (disodiumcromoglycate)
    - systemic antihistamines (cetirizine)
    - 2. topical pulmonary medication excluding inhaled corticosteroids (salbutamol)
    - topical nasal and/or pulmonary corticosteroids (mometasonfuroate, budesonide)
    - 3. systemic corticosteroids (methylprednisolone 2mg/kg b.w.) for three days
    - The rescue medication score of a patient is the area under the curve of all daily rescue medication scores of this patient including all days of the pollen season.

    The investigator will be responsible for an accurate instruction of the patient including an appropriate documentation of the drug account. Rescue medication will be provided to the patient before the start of the pollen season.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The trial ends after the last visit of the last patient undergoing the trial. The principal investigator may terminate the study at any time, for safety reasons. The sponsor may end the study for security, ethical or administrative reasons. In such instances, all investigators shall be notified in writing, outlining reasons for the termination.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    An open follow-up treatment with the active substance for up to 3 years is offered to the patients.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2004-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-08-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-08-24
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